ChiCTR2600120052 版本V1.0 版本创建时间2026/03/09 10:18:57 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2600120052 

最近更新日期:

Date of Last Refreshed on:

2026-03-09 10:18:40 

注册时间:

Date of Registration:

2026-03-09 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

泌尿外科住院医师的尿动力学教学现状与需求调查

Public title:

Survey on the Current Situation and Demand of Urodynamic Teaching for Residents in Urology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

泌尿外科住院医师的尿动力学教学现状与需求调查

Scientific title:

Survey on the Current Situation and Demand of Urodynamic Teaching for Residents in Urology

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

丛志成 

研究负责人:

王钊 

Applicant:

Cong Zhicheng 

Study leader:

Wang Zhao 

申请注册联系人电话:

Applicant telephone:

+86 139 1937 5293

研究负责人电话:

Study leader's
telephone:

+86 151 1635 8241

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

1054219213@qq.com

研究负责人电子邮件:

Study leader's E-mail:

xywangz07@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

湖南省长沙市开福区湘雅路88号中南大学湘雅医院学生公寓

研究负责人通讯地址:

湖南省长沙市开福区湘雅路87号中南大学湘雅医院

Applicant address:

Student Dormitory, Xiangya Hospital, Central South University, No. 88 Xiangya Road, Kaifu District, Changsha, Hunan, China

Study leader's address:

Xiangya Hospital, Central South University, No. 87 Xiangya Road, Kaifu District, Changsha, Hunan, China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

中南大学湘雅医院泌尿外科

Applicant's institution:

Department of Urology, Xiangya Hospital, Central South University

研究负责人所在单位:

中南大学湘雅医院泌尿外科

Affiliation of the Leader:

Department of Urology, Xiangya Hospital, Central South University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

伦审科简第(2026020301)号

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中南大学湘雅医院临床医学伦理审查委员会

Name of the ethic committee:

Medical Ethics Review Committee of Xiangya Hospital, Central South University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-10 00:00:00

伦理委员会联系人:

肖佩君

Contact Name of the ethic committee:

Xiao Peijun

伦理委员会联系地址:

湖南省长沙市开福区湘雅路87号

Contact Address of the ethic committee:

No. 87 Xiangya Road, Kaifu District, Changsha, Hunan, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 731 8432 7919

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

中南大学湘雅医院

Primary sponsor:

Xiangya Hospital Central South University

研究实施负责(组长)单位地址:

中国湖南省长沙市开福区湘雅路87号

Primary sponsor's address:

No. 87, Xiangya Road, Kaifu District, Changsha, Hunan, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hunan

City:

Changsha

单位(医院):

中南大学湘雅医院

具体地址:

中国湖南省长沙市开福区湘雅路87号

Institution
hospital:

Xiangya Hospital Central South University

Address:

No. 87, Xiangya Road, Kaifu District, Changsha, Hunan, China

经费或物资来源:

中南大学湘雅医院

Source(s) of funding:

Xiangya Hospital Central South University

研究疾病:

无  

Target disease:

None

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

描述我国当前研究生培养体系下,泌尿外科专业型研究生对尿动力学知识的了解程度,并分析其学习需求与重难点,为后续开发针对性教学模式(如整合CBL的碎片化学习法)提供依据  

Objectives of Study:

To describe the level of knowledge about urodynamics among professional?type residents in urology under the current postgraduate training system in China, and to analyze their learning needs, key points and difficulties, so as to provide a basis for the subsequent development of targeted teaching models (such as fragmented learning integrated with CBL).

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

拟纳入自2026年1月起,正在中南大学湘雅医院进行泌尿外科专业住院医师规范化培训学员,并纳入同期在其它合作医院培训的部分同类学员,比例约为1:1

Inclusion criteria

This study plans to enroll trainees who are undergoing standardized residency training in Urology at Xiangya Hospital, Central South University starting from January 2026, as well as a proportion of similar trainees receiving training at other cooperative hospitals during the same period, with an approximate ratio of 1:1.

排除标准:

非泌尿外科专业的规范化培训学员

Exclusion criteria:

non-Urology standardized residency trainees

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-12 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

200

Group:

Observational group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖南省 

市(区县):

 

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学湘雅医院 

单位级别:

三甲 

Institution
hospital:

Xiangya Hospital Central South University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

关于泌尿外科住院医师尿动力学理论的学习现状

指标类型:

主要指标

Outcome:

Current Status of Urodynamic Theoretical Learning Among Residents in Urology

Type:

Primary indicator

测量时间点:

测量方法:

问卷数据收集

Measure time point of outcome:

Measure method:

Questionnaire data collection

指标中文名:

关于泌尿外科住院医师尿动力学临床实践的现状

指标类型:

主要指标

Outcome:

Current Status of Urodynamic Clinical Practice Among Residents in Urology

Type:

Primary indicator

测量时间点:

测量方法:

问卷数据收集

Measure time point of outcome:

Measure method:

Questionnaire data collection

指标中文名:

关于泌尿外科住院医师尿动力学的理论教学需求

指标类型:

主要指标

Outcome:

Demands for Urodynamic Theoretical Teaching Among Residents in Urology

Type:

Primary indicator

测量时间点:

测量方法:

问卷数据收集

Measure time point of outcome:

Measure method:

Questionnaire data collection

指标中文名:

关于泌尿外科住院医师尿动力学的实践教学需求

指标类型:

主要指标

Outcome:

Demands for Urodynamic Practical Teaching Among Residents in Urology

Type:

Primary indicator

测量时间点:

测量方法:

问卷数据收集

Measure time point of outcome:

Measure method:

Questionnaire data collection

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

在试验完成后3月,公众可通过邮箱,电话等方式向研究团队内研究者联系,索取原始数据。在研究团队初步审核后,我们可向其公开已隐去受访者相关身份信息的研究原始数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Three months after the completion of the trial, the public may contact the investigators of the research team via email, telephone, or other means to request access to the raw data. Following preliminary review by the research team, de-identified raw research data will be provided to the requesters.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

正式调查问卷通过问卷星平台发放并回收,问卷设计包括理论知识、实践操作、报告书写、疾病解释、适应症和禁忌症掌握等5个方面。数据收集完成后,将通过问卷星导出相关数据,数据存储拟基于医院内网开展,以确保数据安全。所得数据将使用SPSS等统计分析工具进行具体分析。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The formal questionnaire will be distributed and collected via the Wenjuanxing (Questionnaire Star) platform. The questionnaire covers five domains: theoretical knowledge, practical operation, report writing, disease explanation, and mastery of indications and contraindications. Upon completion of data collection, relevant data will be exported from Wenjuanxing. Data storage will be conducted via the hospital intranet to ensure data security. The collected data will be statistically analyzed using tools such as SPSS.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-03-09 10:18:40